MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-24 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[146079787]
(b)(6). Occupation: midwife. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[146079788]
It is reported during labor induction using a cook cervical ripening balloon w/stylet for pre-induction in an outpatient setting, an unspecified number of patients have experienced transverse lie and/or umbilical cord prolapse. No product malfunction was reported. No additional consequences to the patients have reported. Additional information has been requested to clarify number of patients involved, as well as patient/event details. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01261 |
| MDR Report Key | 8640833 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-24 |
| Date of Report | 2019-07-01 |
| Date Mfgr Received | 2019-06-07 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2019-05-24 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-24 |